Case Study

Health Canada Regulatory Modernization: Yesterday, Today, And Tomorrow

Health Canada Regulatory Modernization: Yesterday, Today, And Tomorrow

Health Canada Regulatory Modernization: Yesterday, Today, And Tomorrow by Oxana Iliach, PhD, Sr. Director, Regulatory Strategy and Policy2 Overview In 2017, Health Canada started a five-year initiative on improving regulatory review of drugs and devices (R2D2) 1 . The goal of this initiative was to develop an agile regulatory system that supports better access to therapeutic products based on healthcare system needs. The outcome should result in a modern and flexible operational system with an updated infrastructure supported by an appropriate cost recovery framework. This system will allow access to clinical information to the public. To achieve this goal, Health Canada developed a plan for transformation in three major areas: • Collaboration with health partners • Access to

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